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Shantilal Hansraj Ganger, 74, says that he continues to suffer from an infection after an implant surgery. (Express) Johnson & Johnson has been indicted by a government committee for "deleting" essential facts about the aftermath of his ASR knee implant surgeries. More than 3,600 patients with implants remain untraceable, and at least four deaths have been reported among those who have received these implants – this case, filed by the family of a deceased patient, is now before the court supreme.
Radar tells how Johnson & Johnson used a loophole in US law to penetrate the Indian market, as was the case with ASR, another hip implant product, Pinnacle, without any clinical trial in the country, survey conducted by The Indian Express discovered
Pinnacle and ASR were both "defective" but, although the company officially recalled the ASR implant in 2010, it "removed commercially" the Pinnacle device only three years later. This qualified withdrawal means that patients with "multiple complications" of ASR implants are likely to be compensated. But for those who have used the Pinnacle appliance, justice remains a distant dream.
On Monday, Implant Files, an investigation by the International Consortium of Investigative Journalists (ICIJ) and 59 news agencies, including The Indian Express exposed how medical devices are advertised, sold, and sold. implanted surgically throughout the world under gap regulatory systems.
Read also: Defective hip implants: Ministry of Health approves compensation formula
Records show Johnson & Johnson's subsidiary, DePuy, has asked the United States for Authorization from Pinnacle and ASR to pbad both products. The records show that Indian regulators approved both products on the basis of US clearance – without conducting any clinical trials on their own.
The result for many Indian patients was disastrous: seepages of toxic fluid of cobalt and chromium were reported at once. metal-on-metal implants, essentially consisting of a metal bullet in a metal socket at the hip.
"We did not know we were jumping into a well," Rajeev Thukral says in his two-story house in the Rajouri Gardens in Delhi. . Mamta, 50, Rajeev's wife, has a Pinnacle device in one hip and an ASR implant in the other, and both had gone bad.
"Today, her situation is so serious that she can not even get inside an MRI machine. . We also visited a family counselor for mental trauma, "he says. Back in the United States, 8,000 patients joined them to sue Johnson & Johnson in a clbad action lawsuit against "misconduct" in the Pinnacle implant.
See also: SC asks Center for LIP response to find patients
] In November 2017, a Dallas federal jury ordered the company to pay $ 247 million to six patients who reported being injured by "defective" implants. The six complainants claimed that after implantation, the device had resulted in tissue death, bone erosion and other negative side effects.
Nine months later, the North Texas District Court awarded $ 245 million to six other plaintiffs. The court records show that the jury declared "J & J responsible for defects and fraud". The official website of the American law firm McGartland states that the August 29 ruling covers "past and future medical expenses, punitive damages, as well as pain and suffering."
In India, while Pinnacle pbaded under the radar, ASR was at the center of a series of investigation reports published by The Indian Express in August, including the main findings of a committee created by the Ministry of Health to review complaints from hospitals and patients
The committee indicted J & J and recommended that J & J be required to pay at least 20 lakh to each affected patient and that the revision surgery reimbursement program continue until the end of the day. in August 2025.
However, this brought little comfort to Pinnacle users who still say they are "unbearable" after these implants.
"ASR came after Pinnacle.So why the government ignores us?" We spent 15 lakh Rs to get the implant removed.But what about permanent damage? should be held responsible, "says Bhavesh Ganger, an agent in a garment factory in Mumbai.
Bhavesh's father, Shantilal Hansraj Ganger, 74, continues to suffer from" intense pain "as a result a "serious infection" caused by the Pinnacle implant on his right hip in 2006 to replace an older device that had successfully completed its life cycle of "more than 12 years."
Read also: Comment Johnson & Johnson returns to his word with the regulator [19659009] "My father suffered a hip injury in a road accident, and in 1992, he underwent a replacement surgery, and fourteen years later we went in a private hospital for the new implant.The doctor told us q The Pinnacle device would last 15 to 20 years and the metal-on-metal technology was the best, "says Bhavesh.
"But this time, my father started to feel unbearable pain. in a few weeks. Soon, wounds were formed around the hip and feet, "says the son.
Ganger's medical records show that he even carried out a skin graft on the advice of another doctor. "But again, the wounds have reappeared. The transplant was redone and failed, "says Bhavesh.
In 2013, Ganger's records show that the family finally understood what was wrong. "An examination of the hip revealed that there was an infection around the ball of the joint, as well as fluid-like tissue. The doctor immediately removed the metal bullet from the joint, "he says.
In Delhi, Rajeev's wife, Mamta, said he underwent an initial surgery in Mumbai in April 2006. " I was suffering from rheumatoid arthritis and hip arthroplasty. on the left side with the ASR implant. For the first six months, I had to use crutches. For the right hip, which was also to be replaced, the doctor recommended Pinnacle and the operation took place in December 2007, "she says.
Mamta states that what followed was intense pain in the left hip. "We thought it was due to the difference in leg length. But various tests and an ultrasound showed that the implants of the hip were at fault. There was a collection of fluid around the implants. Our surgeon advised a revision of the left hip in 2009, "she says.
But two other doctors expressed conflicting views. Steroid injections were administered by one of them, while another said that a revision surgery was not necessary.
See also: Facing the FIR, Johnson & Johnson waved a clean note obtained from Judge Srikrishna
two years later, in 2011- 12 after the ASR official reminder, the tests from Mamta again revealed fluid collections around both implants. "We tested the fluid in a British laboratory in 2012. This revealed that cobalt and chromium debris was deposited around the hip. While this was at an alarming level around the ASR implant, the Pinnacle device was also releasing those ions, "says Rajeev.
" Since then, I've had other adverse reactions … cataract in both eyes required surgical procedures, ovarian cysts. who grew up and broke up … an operation for total hysterectomy, less than 3 months apart … then neurological problems, skin pigmentation, thoracic infection, and even my voice s 39; is hoarse, "said Mamta.
his hopes on a revision surgery. "But our fight against the company is not over. We go to court. In 2005, Mamta earned 85,000 rupees a month from an American furniture company. Later, she started her own business and almost immediately generated revenues of 85 lakhs in a year, but we finally closed them … that's the kind of damage that these implants have caused, "says Rajeev.
The Indian Express a spokesman for Johnson & Johnson, said that no adverse event related to the implant had been reported in India. The spokesperson, however, did not answer a specific question about the number of patients who opted for metal-on-metal implants in India.
On Tuesday, the US Food and Drug Administration (USFDA) admitted It is time to fundamentally modernize "the loophole in its legislation that allowed devices such as Pinnacle and ASR to enter the market. The ASR-Pinnacle debacle involves two devices.
Read also: The government knew that Johnson & Johnson had implanted defective hip implants, it took nearly two years before prohibiting them
The first model, DePuy ASR Hip Resurfacing, entered on the Indian market with a CE certification of January 2003 allowing it to be sold in Europe. But it was not marketed in the United States with the refusal of a license by the FDA in August 2009.
The second model, the DePuy ASR XL acetabular system, entered the Indian market with the approval of the USFDA. A "510 (k) FDA clearance" was granted to this product, which means that it was allowed to enter the market based on the conclusion that it was "substantially equivalent" in terms of safety and efficacy at Pinnacle, the prior product recognized by FDA. Both metal-on-metal ASR models were recalled globally by Johnson & Johnson in August 2010.
No adverse events in India & # 39;
In response to a questionnaire from The Indian Express a spokesperson for Johnson & Johnson said:
"At DePuy Synthes we have no greater responsibility than to the patients who use our products. The metal-on-metal ULTAMET hinge was the metal-on-metal rollover option previously available in the PINNACLE acetabular cup system.
"At the end of the metal-on-metal ULTAMET joint design, in the late 1990s, the medical need of the moment for a hip replacement option that could better meet the demands younger and more active patients and help reduce complications with previously available implants. ULTAMET Metal-on-Metal is the result of more than six years of research and development and extensive testing. It is based on strong clinical evidence showing reduced pain and mobility found in patients with chronic hip pain.
"Based on US FDA approval, the ULTAMET Metal-to-Metal Joint was introduced in India in February 2006. DCGI Medical Device Approval Guidelines Started in 2006 a year ago, there was no directive from DCGI for the approval of medical devices. We applied for local approval in June 2006 and the commercialization of this product in India was approved by DCGI in February 2007.
"In 2013, DePuy stopped sales of its ULTAMET metal-on-metal joint worldwide , including in India the demand of clinicians and the availability of alternative options that meet the clinical needs of patients. To date, no adverse events related to the ULTAMET Metal-on-Metal Joint have been reported to the company in India. "
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